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A Clinical Trial of Soluble Fiber for Asthma

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Notable Trial status: Not Yet Recruiting to Recruitingv5 Show 6 more changesShow less
    • Primary and study completion dates: Apr 2027 to May 31, 2027
    • Start date changed from estimate of Dec 2025 to Nov 10, 2025
    • Secondary endpoints: details revised at 1 of 4 entries
    • Study description expanded, about 8 words
    • Site details revised
    • Collaborators: 2 to 4
  2. Notable Start date: Sep 2025 to Dec 2025v4
  3. Notable Start date: Jun 2025 to Sep 2025v3
  4. Notable Start date: Apr 2, 2024 to Jun 2025
    • Trial status: Recruiting to Not Yet Recruiting
    • Interventions: NOVELOSETM 3490 (Drug) to Inulin (Drug)
    • Site details revised
    v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Randomized controlled trial of soluble fiber (Fruitafit Inulin). Participants will complete an ASA 24 dietary recall questionnaire to access their fiber intake. If eligible for the study, participants will be supplemented to their target fiber dosage with either soluble fiber (Fruitafit Inulin) or placebo. Collection of blood serum, fecal samples, and nasal wash will aid in analyzing the microbes present in one's gut and how fiber and diet may impact it. Thus, allowing researchers to better understand the pathways that may connect diet and asthma and if it is possible to improve asthma by altering one's diet.
Trial Details
NCT Number NCT06372249
Lead Sponsor Phoenix Children's Hospital
Collaborators: Northern Arizona University, National Institute on Minority Health and Health Disparities (NIMHD), Southwest Health Engagement and Research Collaborative, SHERC
Conditions
(from sponsor)
Asthma in Children
Related terms Asthma, Environmental Illness, Hypersensitivity
Enrollment 105 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov